Respiratory Dynamics During Birth Stabilization in Preterm Infants Less Than 32+6/7 Weeks Gestation

Impact of Measurement of Respiratory Dynamics During Birth Stabilization in Preterm Infants Less Than 32+6/7 Weeks Gestation

Approximately 50% of preterm infants less than 32 weeks require respiratory assistance at the time of transition at birth. For that stabilization during resuscitation is successful, it is essential for proper ventilation. This transition is performed with non-invasive respiratory support and administration of positive pressure ventilation to establish adequate functional residual capacity. The problem is that a peak inspiratory fixed during ventilation, and adequate tidal volume is assumed, but usually not measured, unable to correct the peak pressure to optimize ventilation and reduce lung damage. In addition, frequent adverse events may hinder or impair the effectiveness of the ventilation, with the consequent deterioration in the prognosis of the newborn.

Study Overview

• Status: Completed
• Conditions: Infant, Premature
• Intervention / Treatment: Other: RFM (device) Visible

Detailed Description

HYPOTHESIS The ability to visualize the parameters and curves respiratory flow, tidal volume and air pressure by respiratory monitoring with MFR during cardiopulmonary resuscitation in newborns in the delivery room, decreases at least 10% surfactant need in first 72 hours of life.

EVALUATION Data collection will be made prospectively. Investigators will measure the parameters of lung mechanics (tidal volume expiratory airflow (TVe), peak inspiratory pressure (PIP), pressure at the end of exhalation (PEEP), inspiratory time (iT)), in each of inflations administered to preterm with VPP or during the administration of continuous positive airway pressure (CPAP) in spontaneous breathing, in the first 10 minutes after birth, recording the air leakage through the mask and obstructions. Investigators also measure parameters of respiratory status and hemodynamic (FIO 2, oxygen saturation, end tidal CO2, respiratory rate, heart rate), patient monitoring during the implementation of the protocol, blood gases, manipulations of the airway during intervention and the onset of complications.

Patients will be randomize in a Group 1, where these parameters of lung mechanics would be visible and other Group 2, where the parameters of TVe and respiratory flow would not be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). Always, in both groups, current recommendations ventilation measures included in cardiopulmonary resuscitation of newborns of the Spanish Society of Neonatology, based on international recommendations (1-3.5) apply. In turn, the results analyzed in two subgroups between 24 and 27 + 6 weeks gestational age and 28 to 32 + 6 weeks.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28009
    • HGU Gregorio Marañon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 minute (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• infants less than 32+6/7 weeks gestational age, birth requiring stabilization with VPP or CPAP in the delivery room.

Exclusion Criteria:

• Congenital Malformations or Chromosomal Aberrations
• Less Than 22 Weeks
• Birth-weight less Than the Third Percentile for Gestational Age According to Spanish Curve
• Severe Perinatal Asphyxia (Apgar Score of 0-3 More Than 5 Min, Cord Blood ph<7.00)
• reanimation unrecorded with video
• no obtained informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RFM Visible; Patients will be randomize in other Group 1, where these parameters (from the device Respiratory Function Monitor) of lung mechanics would be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). We adapt or change PIP using visible TVe.	Other: RFM (device) Visible; Will measure the expire tidal volume, end tidal CO2 and peak pressure changes according to clinical improvement and tidal volume
No Intervention: RFM No Visible; Patients will be randomize in a Group 2, where the parameters of TVe and respiratory flow would not be visible by the rescuer (the usual parameters of PIP and PEEP will be visible). Always, in both groups, current recommendations ventilation measures included in cardiopulmonary resuscitation of newborns of the Spanish Society of Neonatology, based on international recommendations (1-3.5) apply. In turn, the results analyzed in two subgroups between 24 and 27 + 6 weeks gestational age and 28 to 32 + 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduce the need for surfactant.	The aim of this study is to investigate whether the use of MFR during resuscitation of preterm (24-32 + 6 weeks) reduce the need for surfactant.	through study completion, an average of 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for intubation and intermittent mechanical ventilation (iMV)	Avoid intubation and Invasive Mechanical Ventilation in the next three days.	through study completion, an average of 3 days
Incidence of dysplasia bronchopulmonary	Reduce incidence of dysplasia bronchopulmonary	through study completion, an average of 1 year
CPAP on admission to NICU	Number of newborn with CPAP on admission to NICU	through study completion, an average of 1 day
Incidence of mortality		through study completion, an average of 1 year
Measure and get desired tidal volume to optimize resuscitation		through study completion, an average of 1 year
Number of leaks and obstruction during ventilation mask	The aim of this study is to investigate whether the use of MFR during resuscitation of preterm (24-32 + 6 weeks) reduce number of leaks and obstruction during mask ventilation and improves and set the desired tidal volume to optimize resuscitation.	through study completion, an average of 1 day

Collaborators and Investigators

• Sponsor: Manuel Sanchez Luna
• Investigators: Principal Investigator: Gonzalo Zeballos, MD, Gregorio Marañon hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: April 4, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 21, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Premature; Respiratory Function Monitor
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 2014-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No